| アブストラクト | BACKGROUND & AIMS: Zinc-induced copper deficiency (ZICD) is a severe complication of zinc therapy; however, its reporting trends and associated patient characteristics remain unclear. This study aimed to identify clinical patterns and factors potentially associated with ZICD using large-scale pharmacovigilance databases. METHODS: We retrospectively analyzed the Japanese Adverse Drug Event Report database (JADER) and performed a supplementary exploratory analysis using VigiBase. Adult patients receiving oral zinc were included. Multivariable logistic regression explored factors potentially associated with copper deficiency. RESULTS: Among 2646 JADER patients, copper deficiency was reported in 100 (3.8%). Multivariable analysis indicated zinc dosage (per 1-mg/kg/day increase; adjusted reporting odds ratio [aROR], 3.51; 95% confidence interval (CI), 2.51-4.90), chronic kidney disease (CKD; aROR, 9.29; 95% CI, 5.88-14.67), advanced age (>/=70 years; aROR, 1.93; 95% CI, 1.21-3.08), and female (aROR, 1.64; 95% CI, 1.06-2.52) as potential copper deficiency-associated factors, whereas acid suppressants were inversely associated. The median onset was 137 days, occurring earlier in patients with CKD than in those without (119.5 vs. 260 days). Among co-reports with copper deficiency, cytopenia was the predominant adverse event (JADER, 93%; VigiBase, 85%). In VigiBase, these reports were concentrated in the Western Pacific Region (93.5%), where a similar trend was observed for advanced age, but not for female. CONCLUSIONS: Advanced age, CKD, and higher zinc dosages are potentially associated with ZICD. The geographical concentration of reports suggests reporting disparities contributing to a global under-recognition of this complication, necessitating continued international vigilance and rigorous copper and hematological monitoring during zinc therapy. |
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| 投稿者 | Hiyama, Yoko; Yamada, Tomoyuki; Tomota, Emi; Tomita, Takashi; Furukawa, Chisa; Nakamura, Touko; Imai, Hanano; Nagao, Akiko; Sato, Maki; Asada, Mizuho; Goda, Mitsuhiro; Ishizawa, Keisuke; Matsuo, Hiroaki |
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| 組織名 | Department of Pharmaceutical Services, Hiroshima University Hospital, 1-2-3;Kasumi, Minami-ku, Hiroshima 734-8551, Japan; Department of Microbiology,;Graduate School of Biomedical and Health Sciences, Hiroshima University, 1-2-3;Kasumi, Minami-ku, Hiroshima 734-8553, Japan.;Department of Pharmacy, Osaka Medical and Pharmaceutical University Hospital, 2-7;Daigaku-machi, Takatsuki, Osaka 569-8686, Japan. Electronic address:;tomoyuki.yamada.cd@ompu.ac.jp.;Kasumi, Minami-ku, Hiroshima 734-8551, Japan.;Division of Nutrition Management, Hiroshima University Hospital, 1-2-3 Kasumi,;Minami-ku, Hiroshima 734-8551, Japan.;Department of Clinical Pharmacology and Therapeutics, Graduate School of;Biomedical Sciences, Tokushima University, 3-18-15 Kuramoto-cho, Tokushima;770-8503, Japan.;Department of Medical Molecular Informatics, Meiji Pharmaceutical University,;2-522-1 Noshio, Kiyose-shi, Tokyo 204-8588, Japan.;770-8503, Japan; Department of Clinical Pharmacology and Therapeutics, Graduate;School of Biomedical and Health Sciences, Hiroshima University, 1-2-3 Kasumi,;Minami-ku, Hiroshima 734-8553, Japan.;770-8503, Japan; Department of Pharmacy, Tokushima University Hospital, 2-50-1;Kuramoto-cho, Tokushima 770-8503, Japan; Clinical Research Center for;Developmental Therapeutics, Tokushima University Hospital, 2-50-1 Kuramoto-cho,;Tokushima 770-8503, Japan. |
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